The present invention relates to a container for x-ray cassette holders and the like, and more particularly, to an improved sterile container for receiving and enclosing a non-sterile x-ray cassette holder and the like so as to avoid contamination of a sterile operative field by the non-sterile x-ray cassette holder when the x-ray cassette holder is utilized to take x-rays in the sterile operative field during surgery.
For years, it has been general practice to take x-rays of a patient during and after the completion of surgery, and particularly orthopedic surgery, in order to obtain information as to the position of the bones, or for example, of implanted metallic fixations, and in order to obtain a permanent record of the results of the surgery. The x-ray film utilized to take the x-rays has been and is still generally held in x-ray cassette holders having a standard, generally rectangular configuration. As a practical matter, these x-ray cassette holders cannot be sterilized, and it has long been recognized that precautions must be taken when the non-sterile x-ray cassette holders are introduced into the sterile operative field during surgery so as not to contaminate the operative field.
In the past, the accepted practice was to place the unsterile x-ray cassette holders within a sterilized cotton pillow case or mayo table stand cover (actually, an elongated pillow case) prior to the cassette holder being used to take the x-rays during surgery. While such pillow cases or mayo table stand covers generally afforded a somewhat adequate protection against contamination, these cloth pillow cases and cover have the disadvantage that they are pervious to fluids, such as blood and the like, and the leakage of such fluids into pillow cases and covers can cause loss of sterility in the operative field.
Recently plastic, flexible containers have been utilized to enclose unsterile x-ray cassette holders in the sterile operative field, as shown for example in U.S. Pat. No. 3,843,041. While the use of the plastic containers represents an improvement over the use of the cloth pillow cases and mayo table stand covers in that they are impervious to fluids, the presently available plastic containers share a serious disadvantage with the pillow cases and mayo table stand covers. When x-rays are taken in the operative field, the patient is normally unconscious or semi-conscious, and it is difficult to properly position the x-ray cassette holder, enclosed in a container, whether plastic or cotton, so as to provide optimal x-ray views (e.g. standard anterio-posterior and lateral views) without holding the cassette holder.
Commonly the practice has been to prop the x-ray cassette holder against the patient by using sheets or towels, etc. Nevertheless, the patient will oftentimes involuntarily or voluntarily move or the cassette holder will otherwise slip or move relative to the patient after the x-ray holder has been positioned but before the x-ray can be taken. In an attempt to avoid obtaining less than optimal x-ray views because of patient movement or slippage of the cassette holder, x-ray cassette holders were sometimes held in position by the surgeon or one of the other operating room personnel. However, because of fear of repeated x-ray exposures, more and more operating personnel are reluctant to hold the x-ray cassette holders while an x-ray exposure is made. As a result of these problems, surgeons have often, in practice, had to settle for a less than optimal x-ray view.
It is a primary object of my present invention to provide an improved sterile container for receiving and enclosing a non-sterile x-ray cassette holder and the like, which container comprises sterile means for positioning the container, and the x-ray cassette holder therein, with respect to the patient so as to minimize the chances that the cassette holder will slip or otherwise move, with respect to the patient, during the time that the x-rays are being taken and to obviate the need for the operating room personnel to have to hold the container or the cassette holder during exposure of the x-ray film. More specifically, my improved container for x-ray cassette holders and the like includes flexible front and back walls which are joined together along their side and bottom edges and whose top edges define a closable opening for receiving a cassette holder. Sterile fastening means are provided to properly position and maintain the container relative to the patient, and to position and maintain the patient relative to the container. In one illustrative embodiment, which is not to be deemed to limit the forms by which the invention can be manifested, the invention comprises a first pair of sterile straps secured, at their one ends, to the container adjacent to one side edge of the container and extending outwardly from the container. A second pair of sterile straps are secured, at their one ends, to the container along its other side edge and extend from the container in a direction opposite to that of the first pair of straps. Another sterile strap is secured, at its one end, to the container adjacent to its bottom edge and extends from the container.
Each of these sterile straps has a strip of adhesive material applied to one of its surfaces. The outer surface of one of the container walls includes a first zone to which adhesive material has also been applied, with the outer surface of the one container wall facing in the same direction as the one surfaces of the straps. Through the usage of the sterile straps and the first zone of adhesive material, my improved container may be secured to the portion of the patient to be x-rayed without danger of the container moving or being moved, relative to the patient, during the time that the x-ray film is being exposed. Pullaway protective covers overlay each of the adhesive strips and the first zone and may be removed from the straps and the one wall of the container just prior to the securement of my improved container to a patient.
In another embodiment of my improved container, a second zone of adhesive material is applied to the inside surface of the one wall of the container so as to secure the cassette holder to the container. This second zone of adhesive material extends from adjacent to the top edge of the one container wall toward the bottom edge of the container wall and also serves as the means by which the top edges of the front and back container walls may be secured together after a cassette holder has been inserted into the container. As with the first zone of adhesive material, a selectively removable, pull-away protective cover overlies the second zone of the adhesive material so as to facilitate storage of the container prior to usage. This protective cover is designed to be manually pulled away from the underlying adhesive material immediately prior to the insertion of a cassette holder into the container.
In still another alternative embodiment of my present invention, the second zone of adhesive material is omitted. A layer of adhesive material is applied to each of the side surfaces of the x-ray cassette holder to be enclosed within the container and each of these layers of adhesive material has an overlying, pull-away, protective cover. When the cassette holder is to be inserted into the container, the cover protecting one of the layers of adhesive material is pulled away. The cassette holder is introduced into the container, properly positioned therein and then brought into contact with the container wall adjacent to the uncovered layer of adhesive material so that the cassette holder is secured to the container wall. The protective cover overlying the other layer of adhesive material is then removed and the container wall adjacent to the other layer is pressed against the cassette holder, thus firmly securing the x-ray cassette holder within to the container. The open top edges of the container walls, in this alternative embodiment, are closed by a flap which is integrally formed adjacent to one of the top edges and which is designed to be folded over the top edge of the other container wall, after the cassette holder has been inserted into the container, and to be secured to the other container wall by adhesive material applied to the flap.
The improved sterile container of my present invention has a number of commercially important advantages. The container may be manufactured from flexible plastic material at a relatively low cost. This is of consequence since thirty to forty such containers may be required each week by a surgeon. Moreover, my improved container may be sterilized during manufacture and may, itself, be sealed in a package for transport from the manufacturing facility to the hospital. Furthermore, because of its relatively low manufacturing cost, the container can be readily disposed of after usage. This "pre-sterilization" and the "disposability" of my container minimize the work required by the operating personnel and hospital staff and with today's ever increasing hospital costs, this is of particular significance from the standpoint of commercializing my improved container.
These and other objects and advantages of my present invention will become more apparent in view of the following detailed description of the preferred embodiments of my invention described in connection with the accompanying drawings.